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Healthcare Challenges In Indochina
Need for
enhanced healthcare services
Vietnam,
Cambodia and Laos share some similar healthcare
situations. These include the need for improve
occupational health and food safety practices. Better
public education and surveillance will help to control
food-borne diseases and to enhance healthcare services
which can tackle specific problems of the ageing
population at the grassroots level. Measures are also
needed to keep check on non-communicable diseases,
including dental and mental health services.
Need for
more medical products and equipment
The bulk of
medical products and equipment in these countries is
purchased by government hospitals, clinics and healthcare
centres. Expenditure on health items is expected to
increase over the next few years to develop the physical,
infrastructure of healthcare systems and spread over
urban, suburban and rural areas.
In recent years, the market for medical equipment in
Vietnam has boomed with diversified products from leading
manufacturers like GE, Siemens, Philip, Toshiba and
Shimadzu. The government has expanded its healthcare
budget as out-of-date medical facilities need to be
replaced. Some of these requirements include:
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Medical imaging equipment such as CT scanners, X-ray
machines, ultra-sound equipment and angiographs
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Operating theatre equipment such as surgical instruments,
anaesthesia administering machines and disposable medical
instruments
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Intensive care and monitoring equipment
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Equipment for treating cardiac and asthmatic conditions
e.g. respirators and blood oxygen measuring machines
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Diagnostic and laboratory equipment
Local
production of healthcare products is limited to items such
as hospital furniture, simple operation tools and
disposable syringes. The importation climate in Vietnam is
open, without quota and specific shipment license imposed
on imported equipment, although some items would still
require registration and approval from the Ministry of
Health.
Registration Of Medical
Devices In Thailand
(source:
Thai Medical Device Suppliers Association)
Medical
devices vary widely in their complexity and their degree
of risk and benefits. They do not all need the same degree
of regulation. Thus, the Thai FDA places all medical
devices into one of three registration levels based on
level of control necessary to protect Thai-consumers to
get good products in terms of quality, safety, and
effectiveness.
These
three registration levels are:
Level I:
‘Under General Control’
Level I
devices are subject to the least regulatory control, which
requires a Free Sales Certificate issued by the Health
Authority (or a related government body) in the country of
origin of the product.
THAIMED is
officially authorized by the Thai FDA to arrange
pre-screening and verification of Free Sales Certificates
(FSC) for general medical devices (Level I).
While such
screening will continue to be undertaken by the FDA,
THAIMED will do the pre-screening and obtain approval of
the FSC within 3 days, provided documents are in
accordance with the requirements of the Thai FDA.
The
certificate should be issued by a responsible
Ministry/Government Department in the [foreign] country of
origin. However, FSCs may no longer be issued by the
manufacturer or by a Chamber of Commerce and endorsed by a
Government department. Only FSCs issued in English are
acceptable. Furthermore, if the official seal on the
certificate is not English, the words contained therein
must either be translated onto the original document or a
translation, typed on the manufacturer’s stationary and
signed & certified ‘true and correct’ by an authorized
company executive stating his position/title, should be
attached.
According
to the registration requirements, illustrated catalogues,
brochures, or leaflets detailing each product and clearly
showing its model/type and dimensions must be included
when the FSC is submitted to the Thai FDA for approval.
The FSC
provided must be an original document and, once approved
by the Thai FDA, will be valid for 5 years.
The Thai
FDA has accepted the EC Certificate prescribing its
compliance with the EU Directive, IMDD 90/385/EEC and MDD
93/42/EEC, in lieu of a Free Sales Certificate (FSC) for
medical devices in the country that incorporated the MDD
93/42/EEC into national law. THAIMED has a guideline to
submit the EC Certificate in lieu of a FSC. Please contact
Ms. Mallika of THAIMED for more specific information.
Level
II: Detailed report to the Secretary-General of the Thai
FDA
Level II
devices are those for which general controls alone are
insufficient to assure safety and effectiveness, and
existing methods are available to provide such assurance.
Level II devices may include special labeling
requirements, mandatory performance standards and
post-market surveillance.
Examples
of Class II devices are: Physical Therapy Devices,
Alcohol Analyzers, Silicone Breast Implants.
Level
III: Pre-marketing Approval (Granting of a License/
Registration Certificate)
Level III
is the most stringent regulatory category for devices.
Level III devices are usually those that support or
sustain human life, are of substantial importance in
preventing impairment of human health, or which present a
potential, unreasonable risk of illness or injury
Pre-marketing approval is required, following a process of
scientific review to ensure the safety and effectiveness
of Level III devices. All level 3 devices require
pre-marketing approval before they can be imported and
marketed.
Examples
of Class III devices are: Condoms, Examination Rubber
Gloves, Surgical Rubber Gloves, Sterile Hypodermic
Syringes for Single-use, Sterile Single-use Syringes for
Insulin, HIV Test Kits.
(Ref :
http://www.thailandrx.com/registermd.html )
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